• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY DEPUY STEM FEM CEMENTLESS HIGH OFFSET SUMMIT POROCOAT FEMORAL INSERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY DEPUY STEM FEM CEMENTLESS HIGH OFFSET SUMMIT POROCOAT FEMORAL INSERTER Back to Search Results
Model Number LOG372801
Device Problems Break (1069); Entrapment of Device (1212); Tip (3123)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/17/2015
Event Type  Malfunction  
Event Description

Right total hip replacement completed and the postoperative x-ray demonstrated good positioning of implants. However, it was noted that the inserter tip for the femoral had broken free of the inserter and was lodged within the proximal slot of the femoral component. Decision made to not take patient back to operation room to remove secondary to increase risk of post operative infection and complications. Reported to depuy manufacturer rep.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEPUY STEM FEM CEMENTLESS HIGH OFFSET SUMMIT POROCOAT
Type of DeviceFEMORAL INSERTER
Manufacturer (Section D)
DEPUY
warsaw 46582
MDR Report Key4540789
MDR Text Key5515363
Report NumberMW5040836
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/18/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLOG372801
Device Catalogue NumberLOG372810
Device LOT Number584670
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

-
-